FDA Alerts Archive for 2015
January 2, 2015
January 9, 2015
January 10, 2015
January 13, 2015
January 21, 2015
January 23, 2015
February 11, 2015
February 24, 2015
February 25, 2015
March 3, 2015
- Testosterone Products: Drug Safety Communication - FDA Cautions About Using Testosterone Products for Low Testosterone Due to Aging; Requires Labeling Change to Inform of Possible Increased Risk of Heart Attack And Stroke
- Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes: FDA Safety Communication - Design May Impede Effective Cleaning
March 6, 2015
- 0.9 Percent Sodium Chloride Injection, USP, 250 mL VisIV Container by Hospira: Recall - Particulate Matter
- Magnesium Sulfate in 5 Percent Dextrose Injection by Hospira: Recall - Incorrect Barcode Labeling
March 9, 2015
March 10, 2015
March 12, 2015
March 19, 2015
March 23, 2015
March 24, 2015
March 31, 2015
April 2, 2015
April 8, 2015
April 10, 2015
April 17, 2015
April 22, 2015
- Mucinex Fast-MAX Products: Recall - Incorrect Labeling
- Ebola Virus One-Step Test Kits by LuSys Laboratories: Class I Recall - Not Cleared for Marketing
April 24, 2015
- Bupivacaine HCl Injection by Hospira: Recall - Iron Oxide Particulate In Glass Vials
- Injectable Products by Mylan: Recall - Presence of Particulate Matter
May 5, 2015
May 15, 2015
May 19, 2015
May 28, 2015
June 16, 2015
June 24, 2015
July 1, 2015
- Codeine Cough-and-Cold Medicines in Children: Drug Safety Communication - FDA Evaluating Potential Risk of Serious Side Effects
- Unapproved Prescription Ear Drop (Otic) Products: Not FDA Evaluated for Safety, Effectiveness and Quality
July 9, 2015
July 13, 2015
July 16, 2015
July 19, 2015
July 24, 2015
July 27, 2015
- Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI): Drug Safety Communication - FDA Evaluating the Risk of Brain Deposits With Repeated Use
- Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) by Teva Parenteral Medicines: Recall - Particulate Matter
July 30, 2015
July 31, 2015
- Hydrochlorothiazide Tablets by Unichem Pharmaceuticals (USA), Inc: Recall - Potential Presence of Foreign Tablets Contamination
- 0.9 Percent Sodium Chloride Injection, USP (AUTO-C) by Baxter International: Recall - Potential For Leaking Containers, Particulate Matter and Missing Port
August 4, 2015
August 17, 2015
August 18, 2015
August 21, 2015
August 24, 2015
August 28, 2015
- OmniPod (Pod) Insulin Management System by Insulet Corporation: Recall - Possibility of a Higher Rate of Failure
- DPP-4 Inhibitors for Type 2 Diabetes: Drug Safety Communication - May Cause Severe Joint Pain
September 8, 2015
September 10, 2015
- Medistat RX Sterile Drug Products: Recall - Possible Contamination
- Invokana and Invokamet (canagliflozin): Drug Safety Communication - New Information on Bone Fracture Risk and Decreased Bone Mineral Density
September 11, 2015
September 15, 2015
September 17, 2015
September 21, 2015
September 22, 2015
- Avycaz (ceftazidime and avibactam): Drug Safety Communication - Dose Confusion and Medication Errors
September 24, 2015
October 2, 2015
October 15, 2015
October 21, 2015
October 22, 2015
- Kayexalate (sodium polystyrene sulfonate): Drug Safety Communication - FDA Requires Drug Interaction Studies
- Hepatitis C Treatments Viekira Pak and Technivie: Drug Safety Communication - Risk of Serious Liver Injury
October 26, 2015
October 29, 2015
November 6, 2015
November 17, 2015
November 24, 2015
December 2, 2015
December 4, 2015
- Lipo Escultura: Recall - Undeclared Drug Ingredients
- SGLT2 Inhibitors: Drug Safety Communication - Labels to Include Warnings About Too Much Acid in the Blood and Serious Urinary Tract Infections
December 10, 2015
- Pink Bikini Dietary Supplement by Lucy's Weight Loss System: Recall - Undeclared Drug Ingredient
- Baclofen Active Pharmaceutical Ingredient from Taizhou Xinyou Pharmaceutical and Chemical: FDA Statement - FDA Warns of Potential Contamination
December 16, 2015
December 18, 2015
December 23, 2015
- Various Products Distributed for Weight Loss by Bee Extremely Amazed: Recall - Undeclared Drug Ingredients
- La' Trim Plus, Jenesis and Oasis by BeeXtreme: Recall - Undeclared Drug Ingredients
- Apexxx by Nuway Distributors : Recall - Undeclared Drug Ingredient
December 31, 2015
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